Cryoballoon Pulmonary Vein Isolation and Associated Esophageal Effects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 主要终点
- Temperature Decline
研究概览
简要总结
To determine the correlation between rate of temperature decline and nadir cryoballoon temperatures rate of temperature decline and nadir esophageal temperatures during pulmonary vein isolation.
详细描述
When treating atrial fibrillation and targeting various areas in the left atrium, electrophysiologists have the choice to perform ablation with RF energy or cryoenergy. Esophageal ulceration and in more rare cases, esophageal fistulae, are known complications of this ablation procedure. Though rare (0.1-0.25% fistula rate and 15-20% esophageal ulceration rate according to the most recent Heart Rhythm Society EHRA ECA consensus statement)1, the investigators would very much like to understand how to completely prevent these occurrences. Cryoenergy has more recently been introduced as an energy source used in the PVI procedure; therefore, for this energy source, rates of esophageal ulceration are not yet well-defined. Nine esophageal fistulae have occurred in the first approximately 130,000 cryoballoon procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recurrent, symptomatic, drug-refractory, paroxysmal atrial fibrillation with planned cryoballoon pulmonary vein isolation
- •Age >18 years
- •Planned AF cryoablation procedure
排除标准
- •LA diameter >55mm
- •Severe LVH (LV wall ≥ 15mm)
- •LA thrombus
- •Decompensated heart failure
- •Plans for left atrial ablation lesions beyond isolation of the pulmonary veins
- •History of previous pulmonary vein isolation
- •Inability to place esophageal temperature probe or TEE probe
- •Previously documented phrenic nerve injury
- •Known esophageal pathology (complete GI history worksheet)
结局指标
主要结局
Temperature Decline
时间窗: 90 days or when complications resolve
I. To determine the correlation between rate of temperature decline and nadir cryoballoon temperatures rate of temperature decline and nadir esophageal temperatures during pulmonary vein isolation procedure.
Measurements of esophagus to each pulmonary vein
时间窗: 90 days or when complications resolve
II. To accurately measure the distance between the esophagus and the ostium of each pulmonary vein intra-operatively.
Create Recommendations for esophageal temperature-guided ablation
时间窗: 90 days or when complications resolve
To attempt to create recommendations for esophageal temperature-guided ablation in order to increase the safety profile of cryoballoon pulmonary vein isolation (PVI) by providing one center's experience. By trending cryoballoon ablation temperatures and subsequent esophageal temperatures, data trends may emerge and be predictive for esophageal ulceration formation. These trends may include: * Distance between esophagus and pulmonary vein in patients who developed post-ablation esophageal ulcerations * Intra-procedure esophageal temperatures in patients who developed post-ablation esophageal ulcerations * Intra-procedure cryoballoon temperatures in patients who developed post-ablation esophageal ulcerations
Assessment of additional Adverse Events
时间窗: 90 days or when complications resolve
To associate the development of symptoms (including dysphagia, chest pain, fever, "heartburn," or odynophagia) with the presence of ulcerations.
次要结局
- Data collection on Phrenic Injury(90 days or when complications resolve)